Xue-Fu-Zhu-Yu capsule in the treatment of qi stagnation and blood stasis syndrome: a study protocol for a randomised controlled pilot and feasibility trial

Haoqiang He, Guang Chen, Jialiang Gao, Yu Liu, Chenhao Zhang, Chao Liu, Hongzheng Li, Qingyong He, Jun Li, Jie Wang, Haoqiang He, Guang Chen, Jialiang Gao, Yu Liu, Chenhao Zhang, Chao Liu, Hongzheng Li, Qingyong He, Jun Li, Jie Wang

Abstract

Background: Qi stagnation and blood stasis syndrome (QS&BSS) is one of the common Zhengs in traditional Chinese medicine (TCM), which manifests as various symptoms and signs, such as distending pain or a tingling sensation in a fixed position. In recent years, a number of clinical trials have focused on the effectiveness and safety of XFZYC in patients with a QS&BSS subtype disease, such as coronary heart disease, hyperlipidaemia, ischaemic cerebrovascular disease, gastritis, dysmenorrhoea, or arthritis, in terms of the outcomes of relevant diseases. However, there is lack of evidence of the effects of XFZYC in patients with QS&BSS with different diseases, focusing on the outcomes of Zhengs.

Methods/design: A randomised, controlled, pilot and feasibility trial will be employed in this study, using a 7-week study period. Participants will be recruited from Guang'anmen Hospital, Huguosi TCM Hospital, Wangjing Hospital in China. One hundred and twenty participants will be randomised to a treatment group (Xue-Fu-Zhu-Yu Capsule (XFZYC)) and placebo group in a 1:1 ratio. Participants included in the study must be diagnosed with Qi stagnation and blood stasis syndrome criteria. The outcome measurements will include the traditional Chinese medicine patient-reported outcome (PRO) scale for QS&BSS, the single symptom and sign scale of QS&BSS, and the pain scale of QS&BSS. The clinical data management system ( http://www.tcmcec.net /) will be used to collect and manage the data. Quality control will be used, according to Good Clinical Practice (GCP).

Discussion: Previous studies were expected to evaluate whether the addition of XFZYC to standard routine treatment would enhance the treatment effectiveness and improve the biomedical parameters pertaining to relevant disease. However, this trial is focused on the outcome of Zhengs, and we chose a range of outcome measurements to assess the improvement of relevant symptoms and signs. This trial is the first study designed to define and optimise the outcome measurements of Zhengs of XFZYC in the treatment of patients with QS&BSS.

Trial registration: ClinicalTrials.gov, NCT03091634 . Registered on 12 August 2018. Release date 6 May 2017.

Keywords: Chinese medicine; Qi stagnation and blood stasis syndrome; Randomised clinical trial; Xue-Fu-Zhu-Yu capsule.

Conflict of interest statement

Ethics approval and consent to participate

The final revised version of the protocol, informed consent and recruitment poster of this trial have been reviewed and approved by Ethics Committee of Guang’anmen Hospital of China Academy of Chinese Medical Sciences (No. 2017-043-ky-01). Written informed consent must be obtained from each participant before enrolment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Content for the schedule of enrolment, interventions and assessments. CRF, case report form

References

    1. Chan M, Leshner A, Fan TP, et al. “The art and science of traditional medicine part 1: TCM today - a case for integration” Produced by the Science/AAAS Custom Publishing Office Sponsored by Contents. Science. 2014;346(6216 Suppl):S1–S25.
    1. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med. 2017. 10.7326/IsTranslatedFrom_M17-2977_1.
    1. Hou J, Wang J, Lin C, et al. Circulating microRNA profiles differ between qi-stagnation and qi-deficiency in coronary heart disease patients with blood stasis syndrome. Evid Based Complement Alternat Med. 2014. 10.1155/2014/926962.
    1. He L, Fang M, Chen L, et al. Transcriptome analysis of blood stasis syndrome in subjects with hypertension. J Tradit Chin Med. 2016;36(2):173–180. doi: 10.1016/S0254-6272(16)30024-3.
    1. Chen BH, Shen CY, Su Z. Xuefu Zhuyu capsule for ischemic cerebrovascular disease in 126 cases. World Chinese Med. 2011;6(04):334.
    1. Zhang Y, Zhou A, Liu Y, et al. Exploratory factor analysis for validating traditional Chinese syndrome patterns of chronic atrophic gastritis. Evid Based Complement Alternat Med. 2016. 10.1155/2016/6872890.
    1. Bai JL, Zhang DX. Clinical observation on Xuefu Zhuyu capsule in combination with sodium hyaluronate in the treatment of knee osteoarthritis. Chinese J Tradit Med Traumatol Orthop. 2010;18(03):15–16,19.
    1. Liu HH. “Xue Fu Zhu Yu capsule” for endometriosis dysmenorrhea in 80 cases. Shanghai J Tradit Chinese Med. 2003;37(01):37–38.
    1. Shen BQ, Situ Y, et al. A clinical study on the treatment of chronic pelvic inflammation of qi-stagnation with blood stasis syndrome by Penyanqing capsule. Chin J Integr Med. 2005;11(4):249–254. doi: 10.1007/BF02835784.
    1. Chang JG, Li TY. Clinical observation on treatment of chloasma with qi stagnation and blood stasis by modified Xuefu Zhuyu decoction. Chinese J Aesth Med. 2011;20(08):1304.
    1. Qin L, Meng J, Lang Q, et al. Pattern characteristics in patients with primary liver cancer in different clinical stages. J Tradit Chin Med. 2015;35(1):47–53. doi: 10.1016/S0254-6272(15)30008-X.
    1. Chu FY, Wang J, Yao KW, et al. Effect of Xuefu Zhuyu capsule on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: a randomized controlled trial. Chin J Integr Med. 2010. 10.1007/s11655-010-9999-9.
    1. Yu DY, Wei KB, Wo XD. Clinical and experimental study of xuefu zhuyu tang in treating qi stagnation and the blood stasis type of hyperlipidemia. Zhong Xi Yi Jie He Za Zhi. 1988;8(10):601.
    1. Shi LX. Observation of curative effect of Xuefu Zhuyu capsule on superficial gastritis. Shanxi Med J. 2011;40(10):1026–1027.
    1. Sandra M, Claire L, Michal J, et al. CONSORT 2010 statement: extension to randomized pilot and feasibility trials. BMJ. 2016. 10.1136/bmj.i5239.
    1. Fihn SD, Blankenship JC, Alexander KP, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, preventive cardiovascular nurses association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012;60(24):2564–2603. doi: 10.1016/j.jacc.2012.07.012.
    1. Digestive Disease Branch of Chinese Medical Association Consensus on chronic gastritis in China (Shanghai 2012) Mod Digest Interv. 2013;18:119–128.
    1. Jauch EC, Saver JL, Jr AH, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013. 10.1161/STR.0b013e318284056a.
    1. Burnett M, Lemyre M. No. 345-primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2017;39(7):585–595. doi: 10.1016/j.jogc.2016.12.023.
    1. Osteoporosis Group of Chinese Orthopaedic Associationg Chinese guideline for diagnosis and management of osteoarthritis (2018 edition) Chin J Orthop. 2018;38(12):705–715. doi: 10.3760/cma.j.issn.0253-2352.2018.12.001.
    1. Wang J, An Y, Li ZL, et al. Development of PRO scale for qi stagnation and blood stasis syndrome. Chinese J Exp Tradit Med Formulae. 2018. 10.13422/j.cnki.syfjx.20183101.
    1. Wang SQ, Gao Y, Wu SX. Thoughts on the clinical evaluation method of new medicine of syndrome TCM. World Chinese Med. 2014;9:1093–1095.
    1. Eldabe S, Lloyd A, Verdian L, et al. Eliciting health state utilities from the general public for severe chronic pain. Eur J Health Econ. 2010. 10.1007/s10198-009-0178-x.
    1. Zhang X, Chen W, She B, et al. The efficacy and safety of Jian-Wei-Qu-Tong pills for the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome): study protocol for a phase II, randomized controlled trial. Trials. 2014;15(1):272. doi: 10.1186/1745-6215-15-272.
    1. Zhang YJ, Huang XY. Blood rheology and heart function between qi stagnation and qi-deficiency in coronary heart disease patients with blood stasis syndrome. Liaoning J Tradit Chinese Med. 1996. 10.1186/1745-6215-15-272.
    1. Wang J, Li J, Yang G. Research on the association among TCM syndrome, t-PA and PAI in serum and the risk stratification of UA. China J Tradit Chinese Med Pharmacy. 2009;24(9):1133–1136.
    1. Song WY, Zhu QJ, Zhou KB, et al. Expression and clinical significance of neuropeptide Y in different TCM syndromes of vitiligo. J New Chinese Med. 2005;37(2):17–18.00.
    1. Ni YP, Chen JN. Study on relationship between the marks of inflammation and syndrome differentiation of traditional Chinese medicine in hyperlipidemia patients. Liaoning J Tradit Chinese Med. 2007;34(1):7–8.
    1. Wu HJ, Ma ZC, Gao Y, et al. Study on GAP in blood-stasis type of coronary heart disease by using proteomic technique. Chinese J Integrat Med Cardio/Cerebrovasc Dis. 2005;3(03):189–191.
    1. Zhu MD, Du WX, Wei CC, et al. Metabolomic study on coronary heart disease patients with different Chinese medicine pattern. J Tradit Chin Med. 2013;54(17):1489–1493.
    1. Liu L, Cheng Y, Zhang H. Phytochemical analysis of anti-atherogenic constituents of Xue-Fu-Zhu-Yu-tang using HPLC-DAD-ESI-MS. Chem Pharm Bull. 2004;52(11):1295. doi: 10.1248/cpb.52.1295.
    1. Zhang QY, Wang QL, Su JF. Angiogenesis effects of Xuefu Zhuyu decoction and VEGF protein expression of rats with acute myocardial ischemia. Chinese J Inform Tradit Chinese Med. 2011;18(2):53–54.
    1. Song J, Chen WY, Wu LY, et al. A microarray analysis of angiogenesis modulation effect of Xuefu Zhuyu decoction on endothelial cells. Chin J Integr Med. 2012. 10.1007/s11655-012-1143-6.
    1. Lee JJ, Hsu WH, Yen TL, et al. Traditional Chinese medicine, Xue-Fu-Zhu-Yu decoction, potentiates tissue plasminogen activator against thromboembolic stroke in rats. J Ethnopharmacol. 2011. 10.1016/j.jep.2011.01.033.
    1. Wang J, Yang X, Chu F, et al. The effects of Xuefu Zhuyu and Shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013. 10.1155/2013/896467.
    1. Xing Z, Xia Z, Peng W, et al. Xuefu Zhuyu decoction, a traditional Chinese medicine, provides neuroprotection in a rat model of traumatic brain injury via an anti-inflammatory pathway. Sci Rep. 2016. 10.1038/srep20040.

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